Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-02 @ 9:11 AM
Study NCT ID:
NCT04973566
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label Study to Investigate Drug-Drug Interaction (DDI) Potential of Nipocalimab With Coadministration of Etanercept or Hydroxychloroquine in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to assess the effect of nipocalimab on the pharmacokinetic (PK) of etanercept (Part 1); and to assess the effect of hydroxychloroquine (HCQ) on total serum immunoglobin G (IgG) reduction by nipocalimab (Part 2) in healthy participants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: